The Efficacy and Safety of Bilastine in the Treatment of Perennial Allergic Rhinitis in Patients with Moderate and Severe Forms of the Disease. Comparison of bilastine 20 mg with desloratadine 5 mg Сергей

Background: Bilastine is a new non-sedating H1 antihistamine approved for the symptomatic treatment of allergic rhinoconjunctivitis (ARC) and urticaria in adults and children over 12 years of age. In this paper, bilastine was compared with desloratadine in the treatment of various forms of allergic rhino-conjunctivitis classified according to the ARIA recommendations.Materials and Methods: This was an international, multi-centre, open-label, prospective randomized, parallel-group, phase III study which enrolled a total of 226 patients with ARC. The diagnosis of the allergic rhino-conjunctivitis was established on the basis of nasal and non-nasal symptoms and confirmed by the skin prick test. Patients were randomized to one of the two treatment groups: bilastine 20 mg daily or desloratadine 5 mg daily.Results: The results for the primary and secondary endpoints showed a comparable reduction in TSS, NSS, and NNSS from the baseline to the end of the treatment between the treatment groups, with slightly better effects for bilastine. Additional tests carried out in the subgroup of patients with moderate / severe persistent (MSP) ARC demonstrated comparable results for the bilastine and desloratadine groups regarding the mean change in TSS from the baseline until the 28th day, except for the sneezing score, for which bilastine showed the higher response (-1.60 ± 0.60 vs. -1.39 ± 0.63), and a statistically significant difference between the treatment groups regarding AUC for TSS ( -26.07 [95% CI: -48.6, -3.53] p = 0.024), NNSS (-10.51 [95% CI:-19.42, -1.59] p = 0.021), the sneezing score (-4.79 [95% CI:-9.06, -0.51] p = 0.028) and the ocular redness score (-5.50 [95% CI: -8.91, -2.08] p = 0.02).Conclusion: In general, bilastine and desloratadine showed a comparable efficacy profile in the treatment of ARC; however, the results obtained in the subgroup of patients with moderate / severe persistent symptoms indicate that bilastine has a stronger therapeutic effec

The relationships of IRS-1 polymorphism with hemodynamic disorders in hypertensive patients depending on body weight and metabolic comorbidity

The aim: The aim was to study the relationships of IRS-1 gene polymorphism with indicators of the structural and functional state of the heart and blood vessels in patients with arterial hypertension under conditions of different metabolic comorbidity and body weight. Materials and methods: We examined 340 patients with arterial hypertension with different body weight and different types of metabolic comorbidity and 30 healthy individuals aged 45-55. Anthropometric, Biochemical, Molecular genetic methods, Instrumental, Statistical methods were used. Results: The presence of G/R + R/R genotypes in hypertensive patients with normal body weight was associated with an increase in intima-media thickness (CIMT), pulse wave velocity of carotid artery (cPWV) and lower endothelium-dependent vasodilatation (EDVD) compared with G/G genotype carriers. Hypertensive patients with obesity, carriers of G/R and R/R genotypes displayed more pronounced similar changes in vascular remodeling (higher CIMT, cPWV and lower EDVD) and as well as cardiac remodeling (larger sizes and left ventricular mass (LVM)) compared with G/G genotype carriers. Overweight carriers of the G/R + R/R genotypes were characterized by enlargement of LVM and its sizes, a higher CIMT indicator, but this effect was less than in the comorbidity of hypertension and obesity. In hypertensive patients with hypertension, obesity and type 2 diabetes mellitus, the presence of G/R + R/R genotypes was associated with an increase in left ventricular size, left ventricular mass index (LVMI) and CIMT. Conclusions: The relationships of IRS-1 polymorphism with indicators of cardiovascular remodeling in hypertensive patients depending on body weight and the presence of various metabolic comorbidity have been established

The Efficacy and Safety of Bilastine in the Treatment of Perennial Allergic Rhinitis in Patients with Moderate and Severe Forms of the Disease. Comparison of bilastine 20 mg with desloratadine 5 mg

Актуальность: Биластин – новое неседативное H1-антигистаминное средство, зарегистрированное для симптоматического лечения аллергического риноконъюнктивита (АРК) и крапивницы у взрослых и детей старше 12 лет. В данной работе биластин сравнивали с дезлоратадином в лечении различных форм аллергического риноконъюнктивита, классифицированных в соответствии с рекомендациями ARIA. Материалы и методы: это международное многоцентровое открытое проспективное рандомизированное в параллельных группах исследование III фазы, в которое было включено всего 226 пациентов с аллергическим риноконъюнктивитом. Диагноз аллергического риноконъюнктивита был выставлен на основе назальных и неназальных симптомов и подтвержден результатами кожного прик-теста. Пациенты были рандомизированы на получение биластина в дозе 20 мг/сут или дезлоратадина в дозе 5 мг/сут. Результаты: результаты по первичной и вторичной конечной точке показали сопоставимое снижение общей оценки симптомов (Total Symptoms Score, TSS), оценки назальных симптомов (Nasal Symptoms Score, NSS) и оценки неназальных симптомов (Non-Nasal Symptoms Score, NNSS) относительно исходного уровня к концу лечения между обеими группами лечения при несколько лучших эффектах для биластина. Дополнительные анализы, выполненные в подгруппе пациентов со среднетяжелым/ тяжелым персистирующим (Moderate-Severe Persistent, MSP) АРК, показали сопоставимые результаты для групп биластина и дезлоратадина в отношении среднего изменения TSS относительно исходного уровня к дню 28, кроме оценок чихания, по которым биластин показал более высокий ответ (-1,60 ± 0,60 относительно -1,39 ± 0,63), и статистически значимые различия между группами лечения в отношении площади под кривой (AUC) графиков TSS ( -26,07 [95% ДИ: -48,6, -3,53] p = 0,024), NNS (-10,51 [95% ДИ: -19,42, -1,59] p = 0,021), оценок чихания (-4,79 [95% ДИ: -9,06, -0,51] p = 0,028) и покраснения глаз (-5,50 [95% ДИ: -8,91, -2,08] p = 0,002). Заключение: в целом биластин и дезлоратадин показали сопоставимый профиль эффективности при лечении АРК, однако результаты, полученные в подгруппе пациентов со среднетяжелыми/тяжелыми персистирующими симптомами, свидетельствуют о более сильном терапевтическом эффекте биластина.Background: Bilastine is a new non-sedating H1 antihistamine approved for the symptomatic treatment of allergic rhinoconjunctivitis (ARC) and urticaria in adults and children over 12 years of age. In this paper, bilastine was compared with desloratadine in the treatment of various forms of allergic rhino-conjunctivitis classified according to the ARIA recommendations. Materials and Methods: This was an international, multi-centre, open-label, prospective randomized, parallel-group, phase III study which enrolled a total of 226 patients with ARC. The diagnosis of the allergic rhino-conjunctivitis was established on the basis of nasal and non-nasal symptoms and confirmed by the skin prick test. Patients were randomized to one of the two treatment groups: bilastine 20 mg daily or desloratadine 5 mg daily. Results: The results for the primary and secondary endpoints showed a comparable reduction in TSS, NSS, and NNSS from the baseline to the end of the treatment between the treatment groups, with slightly better effects for bilastine. Additional tests carried out in the subgroup of patients with moderate / severe persistent (MSP) ARC demonstrated comparable results for the bilastine and desloratadine groups regarding the mean change in TSS from the baseline until the 28th day, except for the sneezing score, for which bilastine showed the higher response (-1.60 ± 0.60 vs. -1.39 ± 0.63), and a statistically significant difference between the treatment groups regarding AUC for TSS ( -26.07 [95% CI: -48.6, -3.53] p = 0.024), NNSS (-10.51 [95% CI:-19.42, -1.59] p = 0.021), the sneezing score (-4.79 [95% CI:-9.06, -0.51] p = 0.028) and the ocular redness score (-5.50 [95% CI: -8.91, -2.08] p = 0.02). Conclusion: In general, bilastine and desloratadine showed a comparable efficacy profile in the treatment of ARC; however, the results obtained in the subgroup of patients with moderate / severe persistent symptoms indicate that bilastine has a stronger therapeutic effec

Afatinib vs Placebo as Adjuvant Therapy After Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck: A Randomized Clinical Trial

ImportanceLocoregionally advanced head and neck squamous cell cancer (HNSCC) is treated curatively; however, risk of recurrence remains high among some patients. The ERBB family blocker afatinib has shown efficacy in recurrent or metastatic HNSCC. ObjectiveTo assess whether afatinib therapy after definitive chemoradiotherapy (CRT) improves disease-free survival (DFS) in patients with HNSCC. Design, Setting, and ParticipantsThis multicenter, phase 3, double-blind randomized clinical trial (LUX-Head & Neck 2) studied 617 patients from November 2, 2011, to July 4, 2016. Patients who had complete response after CRT, comprising radiotherapy with cisplatin or carboplatin, with or without resection of residual disease, for locoregionally advanced high- or intermediate-risk HNSCC of the oral cavity, hypopharynx, larynx, or oropharynx were included in the study. Data analysis was of the intention-to-treat population. InterventionsPatients were randomized (2:1) to treatment with afatinib (40 mg/d) or placebo, stratified by nodal status (N0-2a or N2b-3) and Eastern Cooperative Oncology Group performance status (0 or 1). Treatment continued for 18 months or until disease recurrence, unacceptable adverse events, or patient withdrawal. Main Outcomes and MeasuresThe primary end point was DFS, defined as time from the date of randomization to the date of tumor recurrence or secondary primary tumor or death from any cause. Secondary end points were DFS at 2 years, overall survival (defined as time from the date of randomization to death), and health-related quality of life. ResultsA total of 617 patients were studied (mean [SD] age, 58 [8.4] years; 528 male [85.6%]). Recruitment was stopped after a preplanned interim futility analysis on July 4, 2016, on recommendation from an independent data monitoring committee. Treatment was discontinued. Median DFS was 43.4 months (95% CI, 37.4 months to not estimable) in the afatinib group and not estimable (95% CI, 40.1 months to not estimable) in the placebo group (hazard ratio, 1.13; 95% CI, 0.81-1.57; stratified log-rank test P=.48). The most common grade 3 and 4 drug-related adverse effects were acneiform rash (61 [14.8%] of 411 patients in the afatinib group vs 1 [0.5%] of 206 patients in the placebo group), stomatitis (55 [13.4%] in the afatinib group vs 1 [0.5%] in the placebo group), and diarrhea (32 [7.8%] in the afatinib group vs 1 [0.5%] in the placebo group). Conclusions and RelevanceThis study's findings indicate that treatment with afatinib after CRT did not improve DFS and was associated with more adverse events than placebo in patients with primary, unresected, clinically high- to intermediate-risk HNSCC. The use of adjuvant afatinib after CRT is not recommended. Trial RegistrationClinicalTrials.gov identifier: NCT01345669Experimentele farmacotherapi